[Federal Register Volume 60, Number 218 (Monday, November 13, 1995)]
[Proposed Rules]
[Pages 57132-57133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27799]
[[Page 57131]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 165
Beverages; Bottled Water; Proposed Rule
Federal Register / Vol. 60, No. 218 / Monday, November 13, 1995 /
Proposed Rules
[[Page 57132]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 165
[Docket No. 95N-0203]
Beverages: Bottled Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations to exempt mineral water from the allowable level for
aluminum in FDA's quality standard for bottled water. The agency is
also proposing to update the testing methods referenced in the quality
standard for bottled water. Elsewhere in this issue of the Federal
Register, the agency is publishing a final rule to establish a standard
of identity for bottled water. This proposal addresses two related
issues that fell outside the scope of that rulemaking. FDA tentatively
concludes that the proposed actions will promote honesty and fair
dealing in the interest of consumers.
DATES: Written comments by January 29, 1996. The agency intends to make
any final rule based upon this proposal effective 60 days following the
date of publication of the final rule in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4681.
SUPPLEMENTARY INFORMATION:
I. Background
-On January 5, 1993 (58 FR 393), FDA published a proposal in the
Federal Register to establish a standard of identity in Sec.
165.110(a) (21 CFR 165.110(a)) for bottled water. At the same time, the
agency proposed to recodify the standard of quality for bottled water,
which is currently found in Sec. 103.35 (21 CFR 103.35), to Sec.
165.110(b), (c), and (d). In addition, FDA proposed to define
``artesian water,'' ``ground water,'' ``mineral water,'' ``purified
water,'' ``spring water,'' and ``well water.''
-Elsewhere in this issue of the Federal Register, FDA is issuing a
final rule that implements those proposed actions. However, two related
issues, which fell outside the scope of that rulemaking, are discussed
in this document along with the comments that the agency received on
those matters.
A. Exemption for Aluminum
In the January 5, 1993, proposal (58 FR 393 at 396), FDA proposed
to include mineral water in the standard for bottled water and, thus,
to subject mineral water to the requirements of the quality standard
for bottled water. Some allowable levels in the quality standard are
based on the Environmental Protection Agency (EPA) secondary maximum
contaminant levels (SMCL's) that are established for aesthetic reasons
and not for consumer safety. Mineral water with a high mineral content
may not meet these allowable levels. Therefore, the agency tentatively
concluded that certain aesthetically based allowable levels should not
apply to mineral waters (58 FR 393 at 400). Elsewhere in this issue of
the Federal Register, FDA is exempting mineral water from the allowable
levels for color, odor, total dissolved solids, chloride, iron,
manganese, sulfate, and zinc.
FDA stated in the January 5, 1993, proposal that if it established
an allowable level for aluminum, it would propose to exempt mineral
water from that standard because the standard is intended to control
aesthetic properties of the water, and not its effect on the body (58
FR 393 at 401). EPA established an SMCL of 0.2 milligram per liter (mg/
L) for aluminum because of increased turbidity of the water and to
prevent post-treatment precipitation in public water distribution
systems ((56 FR 3526, January 30, 1991). On December 1, 1994 (59 FR
61529), FDA established an allowable level of 0.2 mg/L for aluminum in
bottled water in Sec. 103.35(d)(3)(iv) (recodified as Sec.
165.110(b)(4)(iii)(D) elsewhere in this issue of the Federal Register).
In response to the January 5, 1993, proposal, FDA received one
comment that expressed concern about the proposed allowable level for
aluminum in bottled water and with exempting aluminum in mineral water
from the quality standard, because there are some data that suggest
that there may be a link between aluminum and Alzheimer's Disease and
other adverse health effects. It recommended that FDA maintain an
allowable level of 0.2 mg/L for aluminum in all bottled water.
The agency disagrees with the comment. EPA established a SMCL for
aluminum to control aesthetic properties of the water (turbidity) and
not its effect on the body. Aluminum has been found to be neurotoxic
when injected into the brains of animals and in renal patients dosed
inappropriately with aluminum salts. However, the current evidence
suggests that aluminum neither causes Alzheimer's disease nor
contributes to the expression of Alzheimer's disease (Ref. 1).
Therefore, the agency tentatively concludes that it is appropriate
to exempt mineral water from the allowable level of 0.2 mg/L for
aluminum in Sec. 165.110(b)(4)(iii)(D) because it is an aesthetically-
based (turbidity) allowable level. Accordingly, the agency is proposing
to add a footnote to the list of allowable levels in Sec.
165.110(b)(4)(iii)(D) to provide that when water is labeled as
``mineral water,'' it will be exempt from the allowable level for
aluminum. FDA is not proposing to include bottled waters that are not
conspicuously identified with the term ``mineral'' in this exemption
because consumers will not generally expect to encounter aesthetic
effects typical of high mineral content waters in these bottled waters
products. In addition, the agency is not proposing to exempt mineral
water from the allowable level for turbidity because high turbidity may
interfere with disinfection and microbiological determinations. This
exemption parallels the exemptions in Sec. 165.110(b)(3) and
(b)(4)(i)(A) that FDA is establishing in a final rule published
elsewhere in this issue of the Federal Register that exempts mineral
water from certain other aesthetically based allowable levels.
B. Updating References
In the proposal to establish a standard of identity for bottled
water (58 FR 393, January 5, 1993), the agency proposed to update the
methods referenced in Sec. 165.110(b)(2) and (b)(3) for testing water
for the listed contaminants to the ``Standard Methods for the
Examination of Water and Wastewater,'' 17th edition (1989). Several
comments received in response to that proposal stated that
Sec. 165.110(b)(2) and (b)(3) should be updated and should reference
``Standard Methods for the Examination of Water and Wastewater,'' 18th
edition (1992). However, because the agency failed to state in the
proposal that it intended to update the references to the latest
edition, the comments' requested change did not fall within the scope
of that rulemaking, and a separate rulemaking was necessary to effect
that change.
Title 1, part 51 of the Code of Federal Regulations (1 CFR part 51)
requires the filing and updating of material that has
[[Page 57133]]
been incorporated by reference in the Code of Federal Regulations. The
purpose of the requirement is to ensure the public availability and
accuracy of material that has been incorporated from other sources.
In the Federal Register of October 6, 1993 (58 FR 52042), FDA
proposed to update the reference in Sec. 165.110(b)(2) to the 18th
edition. The agency expects to adopt that modification in a final rule
that will be published in the near future. However, to ensure the
accuracy of methods for testing bottled water, that are referenced in
Sec. 165.110(b)(3), FDA is proposing to update them to reference
``Standard Methods for the Examination of Water and Wastewater,'' 18th
edition (1992). If subsequent editions of the methods referenced are
published before the completion of this rulemaking, the agency intends
to update the references in Sec. 165.110(b)(2) and (b)(3) to reflect
the most recent edition.
II. Environmental Impact
-The agency has determined under 21 CFR 25.24(b)(1) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
III. Analysis of Impacts
FDA has examined the impact of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess the costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). According to Executive
Order 12866, a regulatory action is ``economically significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affecting in
a material way a sector of the economy, competition, or jobs. A
regulation is considered ``significant'' under Executive Order 12866 if
it raises novel legal or policy issues. The Regulatory Flexibility Act
requires agencies to minimize the economic impact of their regulations
on small entities. FDA finds that this proposed rule is neither an
economically significant nor significant regulatory action as defined
by Executive Order 12866. In compliance with the Regulatory Flexibility
Act, the agency certifies that the proposed rule will not have a
significant impact on a substantial number of small entities.
Updating the references is not expected to significantly affect the
content of those references or the cost of complying with regulations
citing those references. FDA requests comments on any costs generated
by updating the references as proposed.
Exempting mineral water from the allowable level for aluminum in
bottled water does not represent a change from the current situation.
There is currently no limitation on the amount of aluminum in mineral
water. Similarly, there is no limitation on the amount of aluminum in
mineral water under this proposal (other than a level that is injurious
to health). The current situation is the baseline in comparison with
which costs and benefits of proposed actions are measured. Therefore,
there are neither costs nor benefits associated with exempting mineral
water from the allowable level for aluminum in bottled water.
IV. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Humphreys, S., Contaminants, Standards, and Monitoring Branch
(HFS-308F), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, memo to Shellee Davis, May 26, 1995.
V. Comments
Interested persons may, on or before January 29, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 165
Beverages, Bottled water, Food grades and standards.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 165 be amended as follows:
PART 165--BEVERAGES
1. The authority citation for 21 CFR part 165 continues to read as
follows:
-Authority: Secs. 201, 401, 403, 403A, 409, 410, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 343A,
348, 349, 371, 379e).
2. Section 165.110 is amended by revising the introductory text of
paragraph (b)(3) and by revising paragraph (b)(4)(iii)(D) to read as
follows:
Sec. 165.110 Bottled water.
* * * * *
(b) * * *
(3) Physical quality. Bottled water shall, when a composite of
analytical units of equal volume from a sample is examined by the
method described in applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 18th ed. (1992), which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (b)(2) of this section), meet the
following standards of physical quality:
* * * * *
(4) * * *
(iii) * * *
(D) The allowable levels for certain chemicals for which EPA has
established secondary maximum contaminant levels in its drinking water
regulations are as follows:
------------------------------------------------------------------------
Concentration in
Contaminant milligrams per
liter
------------------------------------------------------------------------
Aluminum.............................................. 0.21
Silver................................................ 0.1
------------------------------------------------------------------------
\1\ Mineral water is exempt from the allowable level. The exemption is
an aesthetically based allowable level and does not relate to a health
concern.
* * * * *
Dated: November 3, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-27799 Filed 11-7-95; 8:45 am]
BILLING CODE 4160-01-F